Florida Citrus Exchange v. Folsom, No. 15934

• Court: United States Courts of Appeals. United States Court of Appeals (5th Circuit)
• Writing for the Court: HUTCHESON, , and JONES and BROWN, Circuit
• Citation: 246 F.2d 850
• Parties: FLORIDA CITRUS EXCHANGE et al., Appellants, v. M. B. FOLSOM, Secretary of The Department of Health, Education and Welfare, Appellee. Frank R. SCHELL, Appellant, v. M. B. FOLSOM, Secretary of The Department of Health, Education and Welfare, Appellee.
• Decision Date: 28 August 1957
• Docket Number: 15948.,No. 15934

246 F.2d 850 (1957)

FLORIDA CITRUS EXCHANGE et al., Appellants,
v.
M. B. FOLSOM, Secretary of The Department of Health, Education and Welfare, Appellee.
Frank R. SCHELL, Appellant,
v.
M. B. FOLSOM, Secretary of The Department of Health, Education and Welfare, Appellee.

Nos. 15934, 15948.

United States Court of Appeals Fifth Circuit.

July 12, 1957.

Rehearing Denied August 28, 1957.

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COPYRIGHT MATERIAL OMITTED

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J. Hardin Peterson and J. Hardin Peterson, Jr., Lakeland, Fla., for Florida, Citrus Exchange, et al

J. Lewis Hall, Tallahassee, Fla., for Frank R. Schell.

William W. Goodrich, Asst. Gen. Counsel, John T. Grigsby, Atty. Criminal Div., Warren Olney, III, Asst. Atty. Gen., Dept. of Justice, Washington, D. C., for appellee.

Vincent A. Kleinfeld, Washington, D. C., for Chase & Co. et al., as amici curiae.

Before HUTCHESON, Chief Judge, and JONES and BROWN, Circuit Judges.

JONES, Circuit Judge.

In the nineteen-thirties growers and packers of oranges in Florida and Texas began the practice of adding color to the rind of oranges. Early oranges, maturing during warm weather, will ripen to full maturity with the skin still green in color. Oranges maturing in the late winter or spring may fully ripen and undergo a "regreening" of the rind. The orange-purchasing public requires an orange-colored orange and will not accept those with green rinds. Representatives of a substantial number of those engaged in the growing and marketing of citrus fruits in the two states assert that severe economic reverses would result from a prohibition of adding color to the fruit; indeed it has been asserted that the future of the orange industry of these states is dependent upon the continued coloring of its product.

In 1938 the Congress enacted the present Federal Food, Drug, and Cosmetic Act. 52 Stat. 1040, 21 U.S.C.A. §§ 301-392. The adulteration of food in interstate commerce and the introduction of adulterated food into interstate commerce were prohibited. 21 U.S.C.A. § 331. Congressional standards for determining when food would be deemed adulterated were set up.¹ Provisions

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for tolerances of poisonous and deleterious substances were included.²

The Secretary of Agriculture, to whom the administration of the Act was originally committed, issued regulations on May 4, 1939, effective May 9, 1939, governing the listing of coal-tar colors.³ Among those eligible for certification were listed F D & C Orange No. 1, F D & C Orange No. 2, and F D & C Red No. 32.⁴ In 1954 the Secretary of Health, Education and Welfare, succeeded to the administration of the Act in the place originally held by the Secretary of Agriculture.⁵ The Secretary reached the conclusion that the three colors are not "harmless" as that word is used in Section 406(b) of the Act. 21 U.S.C.A. § 346(b). An order promulgating a further regulation⁶ was issued by which the three colors were deleted from the list approved for certification for use in foods and in drugs to be taken internally. By Section 701(f) of the Act,⁷ any person who will be adversely affected by an order of the Secretary may file a petition for review with the court of appeals for the circuit wherein such person resides. Petitions for review were filed in three circuits. In the Seventh Circuit the proceeding for review was dismissed. In the Second Circuit, by a decision which we shall hereafter discuss, the Secretary's order was affirmed. Certified Color Industry Committee v. Secretary of Health, Education and Welfare, 2 Cir., 1956, 236 F.2d 866. Two petitions for review have been filed in this Circuit, one by Florida Citrus Exchange and others, orange growers and packers of Florida and Texas, and the other by Frank R. Schell, the holder of patents on the process for the coloring of citrus fruits with Orange 2 and Red 32. The two proceedings for review in this Court have been consolidated. Red 32 is the only one of the three colors with which we are concerned in this proceeding.

The three colors were on the original list, prepared in 1939, of coal-tar colors available for certification. Some of the coal-tar colors on the list became suspect as toxic and possibly carcinogenic. This prompted further investigation which culminated in the hearings which formed the bases of the order which we here review. At the hearing evidence was introduced

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that rats did not survive a diet of 1000 parts per million of Red 32. A dog fed 100 parts per million of Red 32 sickened and ultimately died. This was the lowest percentage tested of Red 32. Evidence was introduced at the hearing which showed that Red 32, when used for coloring oranges penetrated the skin for a depth of about 1/1000 of an inch; that peel of the colored orange had from 17.63 to 34.26 parts per million of color; candied orange peel had 7.4 parts per million of color; orange marmalade analyzed 1.8 parts per million of color; and the squeezed juice of colored oranges had a color content range of from 4/100 of one part per million to 7/100 of one part per million. A spokesman for the entire coal-tar color industry stated that the sale of Red 32 had been discontinued for any purpose except the coloring of oranges. The principal witness for the Secretary was Dr. Vos, Assistant Chief of the Division of Pharmacology of the Food and Drug Administration. He reviewed the tests made upon animals. He testified that on the basis of the experiments and his education and experience he was of the opinion that Red 32 was not a "harmless coal-tar color". On cross-examination he stated that he used the word "harmless" in the absolute sense that the color was capable of producing harm. This was developed by his saying that bad results might follow the taking of two or three ounces of salt but, salt being essential, it would not be regarded as harmful. He had no evidence as to whether the color would produce harmful effects at ordinary levels of use, although he gave an affirmative answer to the question "Aren't the amount and method of proposed use of a material necessary data for deciding whether the material is harmless for the use intended?"

The order of the Secretary which we here review made findings of fact based upon the evidence of the tests of which Dr. Vos testified. At the conclusion of nine paragraphs of specific findings as to the effects of the various quantities of the colors given to animals with mention of one episode of illness resulting to man from eating popcorn colored with Orange 1 where the percentage level did not appear, the Secretary stated:

"There was no evidence on which findings could be made concerning how much of the three colors is likely to be ingested by man from his food, drugs, and cosmetics. Some interested persons, taking their own products, attempted to show that the amounts ingested would be small to the point of insignificance. But those contentions leave aside the occurrence of the colors in the products of others, as well as the fact that upon certification of a color the Department has no means of controlling the amounts of colors used in a variety of food, drugs, and cosmetics. Nor is there authority to limit a color, once certified, to a single food — for example, F D & C Red No. 32 for use in color-added oranges."

By the order it was determined that Red 32 and the other two suspect coal-tar colors were not harmless and suitable for use in food, drugs and cosmetics and these colors were deleted from the approved list. The legal theory upon which the order was based is found in paragraph 2 of the Secretary's conclusions where it was held:

"Sections 406(b), 504, and 604 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346(b), 354, and 364) provide for the listing of coal-tar colors that are harmless and suitable for use in food, drugs, and cosmetics. The act does not provide any method for listing toxic colors for specific food, drug, or cosmetic uses so as to limit their total use to small enough amounts that the toxicity might be disregarded. Under the statute a toxic color cannot be classified as a harmless color."

The primary attack of the petitioners is upon the correctness of the principle as stated in the foregoing quotation.

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When the order of the Secretary was entered an effort was made to procure an amendment to the Act to require the Secretary to permit Red 32 to be used in coloring oranges until a more acceptable color should be made available. The amendment as originally offered was opposed by the Department of Health, Education and Welfare. The measure, as finally agreed upon by its proponents and representatives of the Department, amended Section 402(c) of the Act by adding thereto the following:

"Provided further, That this paragraph shall not apply to oranges meeting minimum maturity standards established by or under the laws of the States in which the oranges were grown and not intended for processing (other than oranges designated by the trade as `packing house elimination\'), the skins of which have been colored at any time prior to March 1, 1959, with the coal-tar color certified prior to the enactment of this proviso as F.D. & C. Red 32, or certified after such enactment as External D. & C. Red 14 in accordance with section 21, Code of Federal Regulations, part 9: And provided further, That the preceding proviso shall have no further effect if prior to March 1, 1959, another coal-tar color suitable for coloring oranges is listed under section 406". 70 Stat. 512, 21 U.S. C.A. § 342(c).

While this amendment was pending before the House of Representatives where it had its origin,⁸ a committee hearing was held. Before the committee was a letter from the Secretary of Health, Education and Welfare where it was stated that the evidence so far available does not establish what the lowest safe dosage of Red 32 would be to test animals, neither does it establish a likelihood of injury to man from the use of the color on the...